ISMP recently reported that ZAVESCA, marketed in the
US
as miglustat capsules, is also being

marketed in other parts of the world with the active ingredient escitalopram, which is LEXAPRO in the US. Miglustat is primarily used in the treatment of mild-to-moderate type 1 Gaucher disease when enzyme replacement therapy is not a therapeutic option.

Escitalopram is a selective serotonin reuptake inhibitor used for depression and anxiety disorders. Previous articles noted problems where some FDA-approved products have the same brand names as foreign drug products with completely different ingredients.

FDA later published a Public Health Advisory noting that 105
US
brand names are dangerously close to foreign brand names used for different products, and that patients who fill prescriptions abroad may get the wrong drugs.

We recently attended the FDA Public Workshop entitled “Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors.” Three panel discussions related to drug label and package safety and how it is assessed, and one panel discussion focused on many of the more challenging dilemmas in trademark safety (e.g., dual trademarks, suffixes, family names). Panelists represented clinical practice, experts in the field and the pharmaceutical industry. Med-ERRS representatives had the opportunity to present public comments after each panel discussion.

Please pass this newsletter along to your colleagues that work with labels, packaging, their design, testing and safety. See links below for additional information about the meeting.

Please let us know if you will be attending PTMG in Athens this September, as Med-ERRS will be in attendance.

Ask an
Expert

If you have a question related to one of Med-ERRS services or have an industry-specific inquiry, please Click Here and one of our experts will get back to you with an answer.

Med-ERRS Services

Trademark Evaluation: Med-ERRS has developed a service for evaluating the safety of trademarks called the ERRS MODELTM, which incorporates various techniques recommended by the FDA to evaluate the safety of trademarks.

SCREEN-ERR: Helps companies evaluate multiple pharmaceutical trademark candidates at an early stage in the trademark development process.

Package and Label Evaluation : Helps clients create packaging and labels that are easy to understand and consistent with the most current FDA and world wide regulatory authorities.

Safety Consulting : Provides consultative services which are related to a variety of medication safety-related issues.

EVALUATE-ERR: Conducts an in-depth analysis of error reports using data from the client as well as other medication error databases.